By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Medical Director, Pharmacy, Northern California Kaiser Permanente, and Assistant Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA.
Drs. Elliott and Chan report no financial relationships relevant to this field of study.
The FDA has approved a biosimilar to adalimumab (Humira), a recombinant IgGI monoclonal antibody specific for human tumor necrosis factor (TNF). Biosimilars are biological products that are highly similar to the reference product with no clinically meaningful differences in terms of the safety, purity, and potency of the product.1 This is the fourth FDA-approved biosimilar. Adalimumab-atto is marketed as Amjevita.
Adalimumab-atto is indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).1
The recommended dose for RA, PsA, and AS is 40 mg every other week subcutaneously. Some patients not receiving methotrexate may benefit from 40 mg every week.1 For JIA, the dose is 20 mg every other week (15 kg to < 30 kg) and 40 mg every other week for those 30 kg or heavier. For CD and UC, the dose is 160 mg on day one (or 80 mg daily for two consecutive days), 80 mg two weeks later, and a maintenance dose of 40 mg every other week beginning two weeks later. For Ps, the initial dose is 80 mg followed by 40 mg every other week. Adalimumab-atto is available as 20 mg and 40 mg single-use prefilled glass syringes and 40 mg single-use prefilled SureClick autoinjector.
Adalimumab-atto provides an alternative to adalimumab for multiple chronic inflammatory conditions.
Adalimumab-atto is not designated as interchangeable with Humira, which means it cannot be substituted without provider approval.
Adalimumab-atto is approved based on evidence of biosimilarity that includes structural and functional characterization, animal data, human pharmacokinetic and pharmcodynamic data, clinical immunogenicity data, and clinical effectiveness and safety data.2 There were sufficient data for the clinical studies section of the prescribing information for adalimumab-atto to be the same as that for adalimumab, with the exception of pediatric Crohn’s disease, hidradenitis suppurativa, and uveitis.
Adalimumab-atto is the third biosimilar that targets tumor necrosis factor alpha. Based on FDA criteria, it is highly similar to the reference product (Humira) and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. The drug is not interchangeable with the reference product without provider approval. The marketing of adalimumab-atto may be delayed until at least March 2017 because of potential patent litigation and the 180-day Notice of Commercial Marketing provision of the Biologics Price Competition and Innovation Act.3